BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HELIOS 3000 TRACK MOUNTED LIGHT

    MDR report key: 2922343 · Received January 11, 2013

    Report

    Report Number
    1017522-2013-00001
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 17, 2012
    Manufacturer
    PELTON & CRANE
    Product Code
    EAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION BY THE LOCAL PELTON AND CRANE DISTRIBUTOR IT WAS DETERMINED THE SET SCREWS AND ROLL PIN WERE NOT INSTALLED BY THE DISTRIBUTOR DURING INSTALLATION. THE SET SCREWS AND ROLL PIN WILL PREVENT THE LIGHT FROM UNSCREWING FROM THE POL AFTER INSTALLATION. THE PELTON AND CRANE INSTALLATION INSTRUCTIONS CLEARLY STATES TO PROPERLY INSTALL THE SET SCREWS AND ROLL PIN DURING INSTALLATION OF THE TRACK LIGHT. THE INSTALLATION INSTRUCTIONS ALSO LIST WARNINGS TO INSURE THE SET SCREWS AND ROLL PIN ARE PROPERLY INSTALLED. PELTON AND CRANE CONTACTED THE DISTRIBUTOR INSTALLATION MANAGER AND REVIEW WITH THEM THE PROPER INSTALLATION PROCESS OF THE SET SCREWS AND ROLL PIN.

    Description of Event or Problem · 1

    A DENTIST WAS POSITIONING A HELIOS DENTAL LIGHT FOR USE WHEN THE LIGHT UNSCREWED FROM THE COLUMN ASSEMBLY AND FELL DOWN TOWARDS THE FLOOR HITTING THE PT ON THE KNEES. THE PT WENT TO HER PRIMARY PHYSICIAN AND HAD STEROID SHOTS IN BOTH OF HER KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18085 HELIOS 3000 TRACK MOUNTED LIGHT DENTAL LIGHT EAZ PELTON & CRANE HL3T

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other